Cleared Traditional

K172267 - IRENE Thoracolumbar Fixation System

K172267 is the FDA 510(k) clearance for IRENE Thoracolumbar Fixation System by Tianjin Zhengtian Medical Instrument Co., Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K172267 · Tianjin Zhengtian Medical Instrument Co., Ltd. · Orthopedic device
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Mar 2018
Decision
222d
Days
Class 2
Risk

K172267 is an FDA 510(k) clearance for the IRENE Thoracolumbar Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Tianjin Zhengtian Medical Instrument Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on March 6, 2018 after a review of 222 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tianjin Zhengtian Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K172267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2017
Decision Date March 06, 2018
Days to Decision 222 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 122d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172267.
Mega Plus Spine System
K173180 · Bk Meditech, Co., Ltd. · Mar 2018
X-spine Cortical Bone Screw System
K180153 · X-Spine Systems, Inc. · Mar 2018
CD HORIZON™ Spinal System
K173249 · Medtronic Sofamor Danek USA, Inc. · Mar 2018
SeaSpine NewPort Spinal System
K180176 · SeaSpine Orthopedics Corporation · Feb 2018
SEURAT™ Universal Pedicle Screw System
K173185 · Ctl Medical Corporation · Feb 2018
SeaSpine Mariner Pedicle Screw System
K173882 · SeaSpine Orthopedics Corporation · Feb 2018